Efficacy of Empagliflozin or Linagliptin as an Alternative to Metformin for Treatment of Polycystic Ovary Syndrome

NCT05200793 | Unknown Phase 4

• 1 other identifier: 0201566
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to compare the efficacy of Empagliflozin or Linagliptin as an alternative to Metformin for treatment of non-diabetic patients with polycystic ovary syndrome (PCOS).

Conditions

Polycystic Ovary Syndrome (PCOS)

Keywords

PCOS; Empagliflozin; Linagliptin; Metformin

Outcome Measures

Primary Outcomes (5)

• Fertility parameters

  \[luteinizing hormone (LH)

  3-6 months

• Follicle-stimulating hormone

  FSH

  3-6 months

• Free androgen index

  total testosterone \& sex hormone binding globulin (SHBG)

  3-6 months

• Transvaginal ultrasonography

  disappearance of PCOS

  3-6 months

• Menstrual diaries

  regulate menses cycles

  3-6 months

Secondary Outcomes (3)

• Metabolic parameters

  3-6 months

• Lipid profile (metabolic parameters)

  3-6 months

• Inflammatory indices

  3-6 months

Study Arms (3)

Metformin arm (control group)

ACTIVE COMPARATOR

Patients will receive Metformin (1500 mg orally/day) for 12 weeks .

Drug: Metformin 1500 mg

Empagliflozin arm

ACTIVE COMPARATOR

Patients will receive Empagliflozin (25 mg orally/day) for 12 weeks.

Drug: Empagliflozin 25 mg

Linagliptin arm

ACTIVE COMPARATOR

Patients will receive Linagliptin (10 mg orally/day) for 12 weeks

Drug: Linagliptin 10 mg

Interventions

Empagliflozin 25 mg DRUG

This study is to compare the efficacy of Empagliflozin or Linagliptin as an alternative to Metformin for treatment of non-diabetic patients with polycystic ovary syndrome (PCOS)

Also known as: Empagliflozin

Empagliflozin arm

Linagliptin 10 mg DRUG

This study is to compare the efficacy of Empagliflozin or Linagliptin as an alternative to Metformin for treatment of non-diabetic patients with polycystic ovary syndrome (PCOS)

Also known as: Linagliptin

Linagliptin arm

Metformin 1500 mg DRUG

This study is to compare the efficacy of Empagliflozin or Linagliptin as an alternative to Metformin for treatment of non-diabetic patients with polycystic ovary syndrome (PCOS)

Also known as: Metformin

Metformin arm (control group)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: This study is for the treatment of polycystic ovary syndrome (PCOS)
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women diagnosed with PCOS according to National Institute of Health criteria.
• Age: \>18 \<40 years.
• Infertile women (primary or secondary infertility).

You may not qualify if:

• Patients with history of diabetes mellitus (Type 1 or 2).
• Patients with liver or renal dysfunction; inflammatory diseases; autoimmune disease; cancer, acute cardiovascular event within last three months and uncontrolled endocrine or metabolic disease.
• Significantly elevated triglyceride levels (fasting triglyceride \> 400 mg/dL)
• Untreated or poorly controlled hypertension (sitting blood pressure \> 160/95 mm Hg).
• Use of hormonal medications, lipid-lowering (statins, etc.), anti-obesity drugs or weight loss medications (prescription or OTC) and medications known to exacerbate glucose tolerance (such as isotretinoin, hormonal contraceptives, glucocorticoids, anabolic steroids) stopped for at least 8 weeks. Use of anti-androgens that act peripherally to reduce hirsutism such as 5-alpha reductase inhibitors stopped for at least 4 weeks.
• Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status.
• Presence of hypersensitivity to Empagliflozin or other Sodium/glucose cotransporter 2 (SGLT2) inhibitors (e.g. anaphylaxis, angioedema, exfoliative skin conditions).
• Known hypersensitivity or contraindications to use dipeptidyl peptidase-4 (DPP-4) inhibitors (saxagliptin, linagliptin, sitagliptin…).
• Use of Metformin, Thiazolidinediones, glucagon-like peptide-1 (GLP-1) receptor agonists, DPP-4 inhibitors, SGLT2 inhibitors stopped for at least 4 weeks.
• Eating disorders (anorexia, bulimia) or gastrointestinal disorders.
• Having a history of bariatric surgery.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University

Alexandria, 21521, Egypt

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

empagliflozin; Linagliptin; Metformin

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Hanan N Abdel Hafez, PhD

  Professor of Obstetrics and Gynecology, Faculty of Medicine Mansoura University

  STUDY CHAIR

• Ahmed I ElMallah, PhD

  Professor of Pharmacology and Therapeutics, Faculty of Pharmacy Alexandria University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haidy M Sami, Master

CONTACT

+201015299642; gs-haidy.sami@alexu.edu.eg

Noha A Hamdy, PhD

CONTACT

+201005182151; noha.alaaeldine@alexu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pharmacology & Therapeutics, Faculty of Pharmacy, Alexandria University

Study Record Dates

• First Submitted: December 12, 2021
• First Posted: January 21, 2022
• Study Start: December 7, 2021
• Primary Completion: July 1, 2022
• Study Completion: September 1, 2022
• Last Updated: January 21, 2022

Record last verified: 2022-01

Locations

EG (1)